Cleared Traditional

K991369 - ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY

K991369 is an FDA 510(k) clearance for ACCUDIP HOME PREGNANCY AND/OR AIMSTICK ..., manufactured by Germaine Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K991369 · Germaine Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
20d
Days
Class 2
Risk

K991369 is an FDA 510(k) clearance for the ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Germaine Laboratories, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 10, 1999 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Germaine Laboratories, Inc. devices

FDA 510(k) Submission Details - K991369

510(k) Number K991369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1999
Decision Date May 10, 1999
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 136
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K991369.
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · Armkel, LLC · Dec 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · Unipath , Ltd. · Dec 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · Phamatech · Nov 1999
SAS HCG-CHECK
K991193 · Sa Scientific, Inc. · May 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · Unipath , Ltd. · Apr 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · Abbott Laboratories · Feb 1999